`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC
`Patent Owner
`
`_____________________
`
`Case IPR2019-002071
`Patent 9,517,219 B2
`_____________________
`
`PETITIONERS’ EXHIBIT LIST
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
`
`
`
`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`
`Amneal
`Exhibit #
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`1006
`1007
`1008
`
`1009
`
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`1017
`1018
`
`Description
`
`U.S. Patent No. 9,517,219
`Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`Curriculum Vitae for Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`International Patent Application Publication No. WO 2009/061298
`(“Garrett”)
`International Application Publication No. WO 2010/072958
`(“Nadau-Fourcade”)
`Certification for Translation of WO 2010/072958
`U.S. Patent Publication No. 2006/0204526 (“Lathrop”)
`U.S. Patent Publication No. 2010/0029781 (“Morris”)
`Osborne, D.W., “Diethylene glycol monoethyl ether: an emerging
`solvent in topical dermatology products,” J. Cosmetic Derm.
`10:324-329 (2011) (“Osborne I”)
`Physician’s Desk Reference, 65th ed., pp. 599-602 (2011) (ACZONE
`Gel 5% Label)
`U.S. Patent No. 7,820,186 (“Orsoni”)
`Epiduo Product Label, approved December 8, 2008 (“Epiduo
`Label”)
`U.S. Patent Publication No. 2007/0190019 (“Guo”)
`Rowe, R.C. et al. (Eds.), Handbook of Pharmaceutical Excipients,
`6th Ed., Pharmaceutical Press: London, UK (2009)
`Bonacucina, G., et al., “Characterization and Stability of Emulsion
`Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate
`Copolymer,” AAPS PharmaSciTech 10:368-375 (2009)
`(“Bonacucina”)
`U.S. Patent No. 5,863,560 (“Osborne II”)
`File History of U.S. Patent No. 9,517,219
`Declaration of Elaine S. Gilmore, M.D., Ph.D.
`
`
`
`- 1 -
`
`
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`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`Amneal
`Exhibit #
`1019
`1020
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`Description
`
`Curriculum Vitae for Elaine S. Gilmore, M.D., Ph.D.
`Affidavit of Christopher Butler
`Intentionally left blank
`Wozel, D., “Innovative Use of Dapsone” Dermatol. Clin. 28: 599–
`610 (2010) (“Wozel”)
`Thiboutot, D., et al., “Pharmacokinetics of Dapsone Gel, 5%
`for the Treatment of Acne Vulgaris” Clin. Pharmacokinet. 46: 697-
`712 (2007) (“Thiboutot”)
`Nguyen, R. and Su, J., “Treatment of Acne Vulgaris” Pediatrics and
`Child Health 21: 119-125 (2010) (“Nguyen”)
`Williams, H., et al., “Acne vulgaris” Lancet 379: 361–72 (2012)
`(“Williams”)
`Sepineo™ P 600 Brochure
`Barclay, L., “Use of Topical Corticosteroids for Dermatologic
`Conditions Reviewed” Medscape - Jan 21, 2009, accessed from
`https://www.medscape.com/viewarticle/587159_print (“Barclay”)
`Remington: The Science and Practice of Pharmacy, 21st Ed.,
`Lippincott Williams & Wilkins: Baltimore, MD (2005)
`(“Remington”)
`Kim, J-Y., et al., “Rheological properties and microstructures of
`Carbopol gel network system,” Colloid. Polym. Sci. 281:614–
`623(2003) (“Kim”)
`Intentionally left blank
`Spain's Almirall bets on dermatology with $650 million U.S. deal,
`Retrieved from https://www.reuters.com/article/us-allergan-m-a-
`almirall/spains-almirall-bets-on-dermatology-with-650-million-us-
`deal-idUSKBN1KO10N, last accessed October 26, 2018
`Piskin, S. et al. “A review of the use of adapalene for the treatment
`of acne vulgaris,” Therapeutics and Clinical Risk Management 3(4):
`621–624 (2007) (“Piskin”)
`Intentionally left blank
`
`
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`- 2 -
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`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`Amneal
`Exhibit #
`
`Description
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`10412
`
`1042
`
`1043
`
`1044
`
`Andersson, D., “Evonik-Degussa expands its
`cooperation with Alsiano,” Pharma & Healthcare News : 1-10
`(2007)
`Poster Abstracts for the Journal of the American Academy of
`Dermatology 2017 Annual Meeting
`Email dated October 8, 2019 from Liz Hagan to Tyler Liu, Dennies
`Varughese, Adam LaRock and James Trainor regarding conference
`call
`Email dated October 8, 2019 from Tyler Liu to trials@uspto.gov
`requesting authorization to file a motion for additional discovery
`Almirall, LLC v. Taro Pharmaceutical Industries Ltd. and Taro
`Pharmaceuticals, Inc., Case 1:17-cv-00663 [Proposed] Joint
`Pretrial Order, Document 142, February 5, 2019
`Deposition Transcript for Leon H. Kircik, M.D., Case IPR2019-
`00207 (October 4, 2019)
`Deposition Transcript for David W. Osborne, Ph.D., Case IPR2019-
`00207 (October 18, 2019)
`Allergan Announces Agreement to Acquire Aczone® Gel
`5%, Retrieved from
`https://www.businesswire.com/news/home/20080609005407/en/All
`ergan-Announces-Agreement-Acquire-Aczone-Gel-5, last accessed
`on October 7, 2019
`U.S. Patent No. 7,326,408
`Second Declaration of Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`M.R.Pharm.S.
`Second Declaration of Elaine S. Gilmore, M.D., Ph.D.
`
`
`2 Exhibits 1041 and 1042 were served on counsel for Almirall on October 18,
`
`2019.
`
`
`
`- 3 -
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`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`Amneal
`Exhibit #
`
`Description
`
`Inactive Ingredient Search for Approved Drug Products: Frequently
`Asked Questions, Retrieved from https://www.fda.gov/drugs/drug-
`approvals-and-databases/inactive-ingredient-search-approved-drug-
`products-frequently-asked-questions#inactive%20as%20active?, last
`accessed on October 25, 2019
`Lubrizol Technical Data Sheet, Dispersion Techniques for
`Carbopol® Polymers
`Kircik, L.H., “Use of Dapsone 5% Gel as Maintenance Treatment of
`Acne Vulgaris Following Completion of Oral Doxycycline and
`Dapsone 5% Gel Combination Treatment,” Journal of Drugs in
`Dermatology 15(2):191-195 (2016)
`Tanghetti, E., et al., “The Efficacy and Tolerability of Dapsone 5%
`Gel in Female vs. Male Patients With Facial Acne Vulgaris: Gender
`as a Clinically Relevant Outcome Variable,” Journal of Drugs in
`Dermatology 11:1417-1421 (2012)
`Intentionally left blank
`Neutralizing Carbopol® and Pemulen® Polymers in Aqueous and
`Hydroalcoholic Systems, published January 2002 (“Noveon
`Technical Data Sheet”)
`2010 Inactive Ingredient Database, available at:
`http://wayback.archive-it.org/7993/20170112022245/http:/www.fda.
`gov/Drugs/InformationOnDrugs/ucm113978.htm.
`FDA Drug Master File Database, available at:
`https://www.fda.gov/drugs/developmentapprovalprocess/formssubm
`issionrequirements/drugmasterfilesdmfs/default.htm.
`Sullivan, D., et al., “A review of the nonclinical safety of
`Transcutol®, a highly purified form of diethylene glycol monoethyl
`ether (DEGEE) used as a pharmaceutical excipient,” Food and
`Chemical Toxicology 72: 4-50 (2014)
`FDA Inactive Ingredient Database Field Descriptions
`Andersson, D., “Evonik-Degussa expands its cooperation with
`Alsiano,” Pharma & Healthcare News 7:1-10 (2007)
`File History of U.S. Patent No. 9,161,926
`Deposition Transcript for Julie C. Harper, M.D., Case IPR2018-
`00608 (March 11, 2019)
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`
`
`- 4 -
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`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`Amneal
`Exhibit #
`1058
`1059
`1060
`1061
`1062
`1063
`1064
`1065
`1066
`1067
`1068
`1069
`1070
`1071
`1072
`1073
`1074
`1075
`1076
`
`1077
`
`1078
`
`Description
`
`Intentionally left blank
`Intentionally left blank
`Intentionally left blank
`Aczone Gel, 7.5% Label
`Dollars for Docs 2013 - Leon Kircik
`Centers for Medicare and Medicaid Services 2013 - Leon Kircik
`Dollars for Docs 2014 - Leon Kircik
`Centers for Medicare and Medicaid Services 2014 - Leon Kircik
`Dollars for Docs 2015 - Leon Kircik
`Centers for Medicare and Medicaid Services 2015 - Leon Kircik
`Dollars for Docs 2016 - Leon Kircik
`Centers for Medicare and Medicaid Services 2016 - Leon Kircik
`Dollars for Docs 2017 - Leon Kircik
`Centers for Medicare and Medicaid Services 2017 - Leon Kircik
`Dollars for Docs 2018 - Leon Kircik
`Centers for Medicare and Medicaid Services 2018 - Leon Kircik
`Dollars for Docs Aczone
`Declaration of Alexander Klibanov, Case IPR2018-00608
`U.S. Patent No. 9,161,926
`Emails dated from January 10, 2020 to January 13, 2020 between
`James Trainor, Adam LaRock, Elizabeth Hagan, Dennies
`Varughese, and Tyler Liu regarding Dr. Warner’s testimony and
`availability
`[CONFIDENTIAL] Deposition Transcript of Kevin Warner,
`Allergan, Inc. v. Taro Pharmaceutical Industries Ltd., and Taro
`Pharmaceuticals Inc., Civil Action No. 17-663 (D.Del. July 18,
`2018)
`
`
`
`- 5 -
`
`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`Amneal
`Exhibit #
`
`Description
`
`1079
`
`Emails dated from December 31, 2019 to January 23, 2020 between
`James Trainor, Adam LaRock, Elizabeth Hagan, RJ Shea, Dennies
`Varughese, and Tyler Liu regarding the confidentiality of Dr.
`Warner’s deposition transcript
`[REDACTED] Deposition Transcript of Kevin Warner, Allergan,
`Inc. v. Taro Pharmaceutical Industries Ltd., and Taro
`Pharmaceuticals Inc., Civil Action No. 17-663 (D.Del. July 18,
`2018)
`10252301_1.docx
`
`1080
`
`
`
`Respectfully submitted,
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: January 24, 2020
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`
`
`
`- 6 -
`
`
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned “Petitioners’
`
`Exhibit List”, along with Exhibit AMN1078, AMN1079, and AMN1080 were
`
`served in their entirety on January 24, 2020, via electronic mail upon the following
`
`counsel for Patent Owner:
`
`
`
`James Trainor
`
`
`RJ Shea
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`
`Telephone (212) 430-2600
`Facsimile (650)938-5200
`jtrainor@fenwick.com
`rshea@fenwick.com
`
`Jennifer R. Bush
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`Telephone (650) 988-8500
`Facsimile (650) 938-5200
`jbush@fenwick.com
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Elizabeth B. Hagan
`FENWICK & WEST LLP
`1191 Second Avenue, 10th Floor
`Seattle, WA 98101
`Telephone (206) 389-4510
`Facsimile (206)389-4511
`ehagan@fenwick.com
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: January 24, 2020
`1100 New York Avenue, N.W.
`Washington, DC 20005-3934
`(202) 371-2600
`
`
`
`Dennies Varughese, Pharm.D.
`Registration No. 61,868
`Attorney for Petitioners
`
`
`
`
`
`- 7 -
`
`
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